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Comparison the effect of melatonin plus propranolol and propranolol on the improvement of symptoms of migraine headache with sleep disorders in children

Comparison the effect of melatonin plus propranolol and propranolol on the improvement of symptoms of migraine headache with sleep disorders in children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190619043946N1
Enrollment
10
Registered
2020-03-09
Start date
2019-03-21
Completion date
Unknown
Last updated
2020-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine and sleep disorders. Migraine

Interventions

Intervention 1: Intervention group: Consumption of propranolol with dosage 1 mg / kg divided into 2 doses Along One tablet of melatonin 3 mg daily for three months. Intervention 2: Control group: Con

Sponsors

Hamedan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 15 Years

Inclusion criteria

Inclusion criteria: 1- Children aged 5 to 15 years 2. A definitive diagnosis of migraine disease by a neurologist. 3- Rejection of other causes of headache 4. Family consent to attend the project 5. Suitable for the onset of migraine prophylaxis: more than one attack per week, more than a disabling attack (leading to school absenteeism or dysfunction, PEDMIDAS of more than 20 6. Sleep disturbance includes: late sleep, early waking, low sleep, frequent waking up during nighttime sleep.

Exclusion criteria

Exclusion criteria: 1-For any reason, patients tend to continue to study or change the diagnosis. 2- Cases of other underlying illnesses that do not have the ability to use propranolol.

Design outcomes

Primary

MeasureTime frame
Migraine. Timepoint: Patients are evaluated 1 month after treatment and in those who continue to receive treatment at the end of the first three months the rate of recovery is assessed. Method of measurement: The severity of migraine headaches is assessed using the PEDMIDAS method.;Sleep disorders. Timepoint: Patients are evaluated 1 month after treatment and in those who continue to receive treatment at the end of the first three months the rate of recovery is assessed. Method of measurement: Child Sleep Disorder will be assessed using the CSHQ Child Sleep Habits Questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAbbas Ali Abdollahi

Hamedan University of Medical Sciences

abbasali.abdollahi@yahoo.com+98 81 3264 0064

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026